NCT00826254

Brief Summary

Part 1) Bone health after transplantation - possible influence of vitamin K Part 2) Fat metabolism and endocrine parameters - possible predictors for developement of overweight after transplantation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 6, 2011

Status Verified

January 1, 2009

Enrollment Period

3.7 years

First QC Date

January 21, 2009

Last Update Submit

July 3, 2011

Conditions

Bone DensityOverweight

Keywords

vitamin KBone Mineral Densityundercarboxylated osteocalcin

Outcome Measures

Primary Outcomes (1)

  • plasma vitamin K

    1 year

Secondary Outcomes (1)

  • Bone mineral density

    1 year

Interventions

Vitamin KDRUG

180 micrograms vitamin K daily

Also known as: Natto

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • accepted for transplantation

You may not qualify if:

  • not accepted for transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet HF

Oslo, Oslo County, Norway

Location

MeSH Terms

Conditions

Overweight

Interventions

Vitamin KSoy Foods

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesPolycyclic CompoundsFermented FoodsDiet, Food, and NutritionPhysiological PhenomenaVegetable ProductsVegetablesFoodFood and Beverages

Study Officials

  • Liv Forli, Dr

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

  • Liv Forli, Dr

    Oslo University Hospital

    STUDY DIRECTOR

  • Oystein Bjortuft, MD

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

August 1, 2003

Primary Completion

April 1, 2007

Study Completion

December 1, 2011

Last Updated

July 6, 2011

Record last verified: 2009-01

Locations

NO(1)